Adverse Events Module

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Adverse Events Module

For researchers submitting trial data to ClinicalTrials.gov, the Adverse Events module is one of four mandatory results sections. It requires reporting in three primary categories: All-Cause Mortality: A table tracking all deaths that occurred during the study, regardless of cause. Serious Adverse Events (SAEs): A tabular summary of events resulting in death, life-threatening conditions, hospitalization, or significant disability. Other Adverse Events: A table for non-serious events that exceed a specific frequency threshold, such as 5% within any study arm.

Adverse Events Module path is as follows:

Study -> Results Section -> Adverse Events Module -> Event Groups

Study -> Results Section -> Adverse Events Module -> Serious Events

Study -> Results Section -> Adverse Events Module -> Other Events

Adverse Events Module

Ignite Creation Date: 2025-12-25 @ 1:27 AM
Ignite Modification Date: 2025-12-25 @ 11:38 PM
NCT ID: NCT04199793
Description: Adverse event information was collected for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. Adverse events were collected from the time of randomization through participant completion.
Frequency Threshold: 0
Time Frame: Baseline to 180-days
Study: NCT04199793
Study Brief: Lavare Cycle in Patients Receiving HeartWare Left Ventricular Assist Device
Event Groups(If Any):

Event Groups

Title Description Deaths # Affected Deaths # At Risk Serious # Affected Serious # At Risk Other # Affected Other # At Risk View
Lavare Cycle On For the patients randomized to "Lavare On" group, the Lavare™ cycle will be turned on upon device interrogation after patients return to intensive care unit from the operating room. Lavare On: For the patients randomized to "Lavare On" group, the Lavare™ cycle will be turned on upon device interrogation after patients return to intensive care unit from the operating room. 0 None 2 4 0 4 View
Lavare Cycle Off For the patients randomized to "Lavare Off" group, the Lavare™ cycle will be turned off upon device interrogation after patients return to intensive care unit from the operating room. Lavare Off: For the patients randomized to "Lavare Off" group, the Lavare™ cycle will be turned off upon device interrogation after patients return to intensive care unit from the operating room. 0 None 4 4 0 4 View
Serious Events(If Any):

Serious Events

Term Type Organ System Vocab View
Rehospitalization due to low INR SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Rehospitalization SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Rehospitalization SYSTEMATIC_ASSESSMENT Respiratory, thoracic and mediastinal disorders None View
Rehospitalization SYSTEMATIC_ASSESSMENT Infections and infestations None View
Right heart failure SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Rehospitalization SYSTEMATIC_ASSESSMENT Gastrointestinal disorders None View
Ventricular arrhythmia SYSTEMATIC_ASSESSMENT Cardiac disorders None View
Pump/Drive line infection SYSTEMATIC_ASSESSMENT Infections and infestations None View
Other systems infections SYSTEMATIC_ASSESSMENT Infections and infestations None View
Bleeding SYSTEMATIC_ASSESSMENT Blood and lymphatic system disorders None View
Device malfunction alarms SYSTEMATIC_ASSESSMENT Surgical and medical procedures None View
Other Events(If Any):